A STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DAUNORUBICIN AND CYTARABINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

AKKALA SAI VENEELA; GALLA RAJITHA; ASHRITHA NARIKIMALLI

doi:10.22159/ajpcr.2022.v15i5.43682

Authors

AKKALA SAI VENEELA Department of Pharmaceutical Analysis, School of Pharmaceutical Sciences and Technologies, JNTUK, Kakinada, Andhra Pradesh, India. https://orcid.org/0000-0001-9093-4250
GALLA RAJITHA Department of Pharmaceutical Chemistry, Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam, Tirupati, Andhra Pradesh, India.
ASHRITHA NARIKIMALLI Department of Pharmaceutical Analysis, School of Pharmaceutical Sciences and Technologies, JNTUK, Kakinada, Andhra Pradesh, India. https://orcid.org/0000-0001-7337-2778

DOI:

https://doi.org/10.22159/ajpcr.2022.v15i5.43682

Keywords:

Daunorubicin, Cytarabine, RP-HPLC, validation, stability studies

Abstract

Objective: A simple, accurate, and precise method was developed for the simultaneous estimation of daunorubicin and cytarabine dosage form using reverse-phase HPLC and validated with different parameters such as accuracy, precision, repeatability, linearity, limit of detection (LOD), and limit of quantitation (LOQ) as per ICH Q2R1 guidelines.

Methods: The chromatogram was run through Agilent C18 Column of dimensions 150×4.6 mm, 5 m. Mobile phase containing 0.01N KH2PO4: Methanol taken in the ratio 50:50 was pumped through the column at a flow rate of 1.0 ml/min. The temperature was maintained at 30°C. The optimized wavelength selected was 240 nm.

Results: Retention times for daunorubicin and cytarabine were found to be 2.433 min and 3.045 min. The %RSD of the daunorubicin and cytarabine was found to be 0.7 and 0.4, respectively. The %Recovery was obtained as 99.96% and 100.40% for daunorubicin and cytarabine, respectively. LOD and LOQ values obtained from regression equations of daunorubicin and cytarabine were 0.08 μg/ml, 0.24 μg/ml and 0.94 μg/ml, 2.86 μg/ml, respectively. The regression equation for daunorubicin is y=28587x+3141 and y=35995x+37534 for cytarabine.

Conclusion: The method developed was simple and economical that can be adopted in regular quality control tests in industries.

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